Vapor ablation handpiece

ABSTRACT

A vapor ablation handpiece for assisting a physician perform vapor ablation with a vapor ablation catheter includes a vapor generating element arranged in a coil shape. A mandrel seated in the body of the handpiece affixes the vapor generating element in the coiled arrangement. A voltage difference is supplied across the length of the vapor generating element when activated, causing the vapor generating element to heat liquid therein converting the liquid to vapor. The heated condensable vapor is delivered to a target tissue through the catheter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 16/203,541,filed Nov. 28, 2018, and entitled “VAPOR ABLATION HANDPIECE” and claimspriority to Provisional Patent Application No. 62/598,138, filed Dec.13, 2017 and entitled “VAPOR ABLATION HANDPIECE.”

BACKGROUND OF THE INVENTION

The present invention is directed to tissue ablation by directing acondensable vapor at the tissue, and more particularly, to a handpiecefor generating and controlling the condensable vapor to ablate thetissue.

Bronchoscopic vapor ablation is a minimally invasive medical procedurefor treating various pulmonary diseases such as emphysema. Bronchoscopicvapor ablation can be applied to effectively reduce the volume ofdiseased lung tissue in a patient's lung, otherwise known as lung volumereduction surgery (LVRS). LVRS has been shown to improve patientpulmonary function in certain classes of patients.

In a bronchoscopic vapor ablation procedure, a bronchoscope is advancedinto the lung of a patient to observe the target anatomy and to provideaccess to the target anatomy via a working lumen. Next, a vapor deliverycatheter is advanced through the bronchoscope to the diseased lungsegment. Vapor is applied to the target tissue through the catheter,heating the target tissue. Ablating the tissue serves to reduce thevolume of the diseased tissue, allowing healthier tissue to perform thenecessary pulmonary function.

Vapor ablation, however, is not without challenges. A liquid must bedelivered to a vapor generator, the liquid is transformed to vapor, andthe newly created vapor is transported to the catheter. The vapor isthen carried through the catheter to the tissue. Heat loss can ariseanywhere along the flow path. Perhaps worse, delivering too much vaporplaces the patient at risk for collateral damage can occur to healthyportions of the lung.

A number of patents describe systems for supplying a vapor to ablate atarget tissue. U.S. Pat. No. 7,913,698 to Barry et al., e.g., describesmethods and devices for affecting lung volume reduction, preferably forachieving acute or immediate lung volume reduction following treatment.The lung volume reduction is effected by delivering a condensable vaporat a temperature above body temperature to the desired regions of thepatient's lung to damage tissue therein. Blood flow and air flow to thedamaged tissue region is essentially terminated, rendering the targetregion non-functional. See also, U.S. Pat. No. 8,585,645 to Barry et al.

Although the above mentioned patents describe fine systems and methodsfor generating and delivering the vapor, the vapor is created by agenerator remote to the catheter. A shortcoming of generating the vaporremote to the catheter is that heat loss may occur along the vapor flowpath between the generator and catheter. This is undesirable.

Accordingly, there is still a need for improved vapor ablation thateffectively generates, controls and delivers vapor to tissue whileminimizing heat loss.

SUMMARY OF THE INVENTION

A vapor ablation handpiece for assisting a physician perform vaporablation with a vapor ablation catheter includes a vapor generatingelement arranged in a coil shape. A mandrel seated in the body of thehandpiece affixes the vapor generating element in the coiledarrangement. A voltage difference is supplied across the length of thevapor generating element when activated, causing the vapor generatingelement to heat liquid therein converting the liquid to a condensablevapor. The condensable vapor is delivered to a target tissue through thecatheter.

In embodiments, the vapor generating element is an electricallyconducting tube having a plurality of coil turns and the turns areseated in receptacles in the mandrel.

In embodiments, the vapor generating element has an orientation traverseto the barrel of the handpiece.

In embodiments, thermocouples are mounted or incorporated into locationsalong the flow path of the fluid. Temperature information is sent to acontroller to monitor and adjust the voltage applied to the vaporgenerating element. The controller is programmed to adjust thetemperature to maintain a steady flow of vapor through the catheter.

In embodiments, a vapor ablation system has a controller, a fluid supplyto supply liquid, and a handpiece coupling the liquid to an elongatecatheter. The handpiece includes a vapor generating element held in acoiled arrangement by a mandrel. The vapor generating element isoperable with the controller to heat liquid flowing therethrough intovapor, and pass the vapor through the elongate catheter.

In embodiments, the fluid supply is a syringe.

In embodiments, the handpiece includes a cooling element to cool thevapor generating element. A fan is mounted in the body of the handpieceto aim air across the coil turns of the vapor generating element.

In embodiments, a method for ablating tissue with condensable vaporincludes the following steps: providing an electrically conducting tubein a coiled arrangement; maintaining a gap between adjacent coil turns;transporting liquid through the electrically conducting tube; applying avoltage difference across the electrically conducting tube from a firstend to a second end thereby converting the liquid to a condensablevapor; and delivering the condensable vapor to the tissue.

In embodiments, the method further includes the step of cooling the coilturns.

In embodiments, the maintaining step is performed with a mandrel.

In embodiments, the coil is interlocked with the mandrel by threadingthe coil and mandrel together.

In embodiments, the mandrel has a tubular body and is disposed within alumen defined by the coiled arrangement of the electrically conductingtube.

In embodiments, the mandrel has a plurality of exteriorly disposedreceptacles, and each receptacle is sized to engage a coil turn of theelectrically conducting tube.

The description, objects and advantages of the present invention willbecome apparent from the detailed description to follow, together withthe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of a vapor ablation system;

FIG. 2 is a side view of a handpiece of a vapor ablation system with aportion of the handpiece removed to show various components therein;

FIG. 3 is partial side perspective view of a coil assembly in accordancewith one embodiment of the invention;

FIG. 4 is an exploded view of a coil assembly in accordance with oneembodiment of the invention;

FIGS. 5A-5C are perspective, side, and front views respectively of acoil support in accordance with an embodiment of the invention;

FIG. 5D is an enlarged view of a portion of coil support shown in FIGS.5A-5C;

FIGS. 6A-6C are perspective, side, and front views respectively of acoil in accordance with an embodiment of the invention; and

FIG. 7 is a perspective side view of the coil registered with the coilsupport in accordance with one embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

Before the present invention is described in detail, it is to beunderstood that this invention is not limited to particular variationsset forth herein as various changes or modifications may be made to theinvention described and equivalents may be substituted without departingfrom the spirit and scope of the invention. As will be apparent to thoseof skill in the art upon reading this disclosure, each of the individualembodiments described and illustrated herein has discrete components andfeatures which may be readily separated from or combined with thefeatures of any of the other several embodiments without departing fromthe scope or spirit of the present invention. In addition, manymodifications may be made to adapt a particular situation, material,composition of matter, process, process act(s) or step(s) to theobjective(s), spirit or scope of the present invention. All suchmodifications are intended to be within the scope of the claims madeherein.

Methods recited herein may be carried out in any order of the recitedevents which is logically possible, as well as the recited order ofevents. Furthermore, where a range of values is provided, it isunderstood that every intervening value, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range is encompassed within the invention. Also, it iscontemplated that any optional feature of the inventive variationsdescribed may be set forth and claimed independently, or in combinationwith any one or more of the features described herein.

All existing subject matter mentioned herein (e.g., publications,patents, patent applications and hardware) is incorporated by referenceherein in its entirety except insofar as the subject matter may conflictwith that of the present invention (in which case what is present hereinshall prevail).

Reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin the appended claims, the singular forms “a,” “an,” “said” and “the”include plural referents unless the context clearly dictates otherwise.It is further noted that the claims may be drafted to exclude anyoptional element. As such, this statement is intended to serve asantecedent basis for use of such exclusive terminology as “solely,”“only” and the like in connection with the recitation of claim elements,or use of a “negative” limitation. Last, it is to be appreciated thatunless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs.

FIG. 1 illustrates a vapor ablation system 10 which serves to generateand transport a condensable vapor to a target tissue, namely, lung orother tissue.

The vapor ablation system 10 is shown including a catheter 20 andhandpiece 30 to which the catheter is removably joined.

The catheter 20 is shown comprising a distal end 22, an inflatablemember 23, a flexible elongate shaft 24, and a proximal catheter hub 26which may be joined to the handpiece 30. Examples of the catheter andcomponents of the catheter are described in U.S. Pat. Nos. 7,913,698 and8,585,645, both to Barry et al.

The handpiece 30 is shown in the shape of a pistol. The handpiece 30includes a hollow coil 32 serving to convert liquid into a condensablevapor as it passes therethrough. The handpiece is shown with a vaporswitch 34 and a set switch 36 which collectively serve to activate thevapor delivery.

In embodiments, the set switch 36 enables operation of the vapor switch34 for a pre-set period of time (e.g., 10-20 seconds). After the setperiod of time, the vapor switch 34 is disabled for operation.

The handpiece is fluidly and electrically coupled to generator 40 via awater line 38 and electrical or control cable 39 respectively. Anexample of water line 38 is a flexible non-electrically conductivepolymeric tube. Examples of a handpiece operation and various componentstherein are described in US Patent Publication No. 2016/0220297 to Kroonet al.

Generator 40 is shown housing a syringe 42, syringe pump 44, and powersupply 46. The syringe and pump operate together to store and transporta liquid to the heater coil 32 of the handpiece 30 through the waterline 38. Liquid may be sent to and delivered from handpiece continuouslyor in short pulses as desired. Generator 40 may also house various othercomponents including processor(s) and storage components which areprogrammed or operable to carry out the methods described hereinincluding actuating the pump to deliver a predetermined amount of liquidto the handpiece.

A graphical user interface (GUI) 50 (e.g., a tablet) is shown connectedto the generator 40 via a cable 52. However, other interfaces may beemployed including display and keyboard, smartphone, mouse, etc. Thegenerator may be connected to remote GUIs and servers via the internetor other networks. Additionally, a USB key is shown which may includeinstructions thereon to activate the controller within certainparameters or conditions such as, for example, the requirement that thecatheter has not been used previously. In embodiments, the system (viause of the USB key or otherwise) is adapted to prohibit use of thecatheter after a pre-determined number of uses. Examples of generatorsand controller operation and components therein are described in U.S.Pat. Nos. 7,913,698 and 8,585,645, both to Barry et al.

FIG. 2 illustrates another handpiece 100 sharing some of the featuresand functions with the handpiece shown in FIG. 1 . Handpiece 100 has apistol-shaped body 110 including a grip portion 112 and hook 114 forhanging the handpiece when not in use.

Similar to the handpiece described above in connection with FIG. 1 , thehandpiece 100 includes a vapor switch 120 and a set switch 122 whichserve to collectively safely activate vapor delivery.

The handpiece 100 includes a female-type quick connect 130 to accept andregister a proximal end of a vapor delivery catheter such as thecatheter hub 26 described above.

The handpiece 100 is shown with a connector 140 for receiving liquid andthe water line 38 described above. An exemplary connector 140 is astainless-steel female Luer lock connector.

Adjacent the liquid line connector 140 is an opening 142 to receive acable such as the control cable 39 described above. The opening 142 isshown in the form of a rubber grommet. Electrical conductors can extendthrough the opening 142 from the generator and provide signals andcurrent to various components of the handpiece including, e.g., circuitboard 146, light indicator array 148, first electrical terminus 152, andsecond electrical terminus 154. The wire conductors, however, have beenremoved from FIG. 2 in order to facilitate visibility and understandingof the other components in the handpiece discussed herein.

In embodiments, the handpiece 100 includes two PC boards: one boardhouses all the lights. The second board operates the thermocouples,buttons, and light board. Incorporating multiple PC boards into thehandpiece is advantageous because the number of electrical wirestraversing from the handpiece to the generator box is reduced.

Handpiece 100 is also shown having a discrete vapor generating element160 for heating the liquid to vapor. The vapor generating element ofFIG. 2 comprises tube made of an electrically conducting material andarranged in a coil configuration which is traverse to the barrel 115 ofhandpiece. The vapor generating element 160 is shown as a bare orsheath-less discrete element or component. It is shown commencing andterminating within the handle. The vapor generating element 160 may havea uniform wall thickness and electrical resistance along its length. Avoltage difference is applied between the first electrical terminus 152and the second electrical terminus 154 creating a current along thevapor generating element. The vapor generating element is heated due toresistance to the current. The liquid within the coil quickly turns tovapor.

One or more temperature sensors may be incorporated into the fluid pathto measure temperature, and provide temperature information to theprocessor in the handpiece or controller of the vapor ablation system.The controller may adjust voltage to the vapor generating element toraise or lower the temperature. In embodiments, the vapor generatingelement is operable to avoid raising the temperature of the vapor above150° C., and in some embodiments avoids raising the temperature of thevapor above about 115° C.

FIG. 3 is a partial view of an illustration of a heater coil assembly200 including a vapor generating element 210, support 220, housing 230,and fan 240. As described herein, liquid enters the vapor generatingelement 210 at entry region 212 and is heated by the coil walls, turningto vapor. By the time the fluid reaches the exit region 214, the fluidis converted to vapor.

As shown in FIG. 3 , and discussed further herein, the vapor generatingelement 210 is configured as a coil comprising a plurality of loops orturns. The coiled arrangement is held in place on a support 220.

A housing 230 and fan 240 are arranged to direct air across the vaporgenerating element 210 and support 220, serving to cool the assembly andprevent overheating of the handpiece.

FIG. 4 is an exploded view of the coil 210, support 220, and housingwalls 230.

Mandrel—Coil Support

FIGS. 5A-5D illustrate various engineering views of the coil support ormandrel 220 shown in FIG. 4 . As described herein, the mandrel serves tohold the coil 210, maintain a spacing or gap between adjacent coilturns, and avoid acting as a heat sink to the extent possible.

The mandrel 220 is shown having a frame 230, a bridge 240, and aplurality of receptacles 242 a, 242 b, . . . Each receptacle 240 issized to accept and hold an individual coil turn, and maintain a gap (G)between adjacent coil turns. In embodiments, the gap (G) ranges from0.03 to 0.1 inches, and more preferably is from 0.04 to 0.06 inches.

In embodiments, the mandrel has a length (L) ranging from 1-2 inches andmore preferably from 1.5-1.75 inches, and in one embodiment is about 1.6inches. In embodiments, the mandrel 220 has a diameter (D) ranging from1 to 2 inches, and more preferably from about 1 to 1.25 inches.

As described above, the mandrel 220 is shown having a plurality of cupsor receptacles 242 a, 242 b to hold individual coil turns of the tubularmember 210. Particularly, the mandrel shown in FIGS. 5A-5C includes 14receptacles to hold the 14 coil turns of the tube 210. However, thenumber of cups 242 in the bridge 240 may vary and be adjusted toproperly hold or affix the coil 210 in its coiled arrangement.

With reference to FIG. 5D, the receptacles 242 a, 242 b can have aheight (H) ranging from 0.025 to 0.1 and preferably about 0.07 inchesand a width (W) ranging from 0.025 to 0.1 and preferably about 0.08inches. The receptacle or cup is also shown having a concave base toaccept a coil turn of the tube 210 described herein.

The material of the mandrel may vary. An exemplary material for themandrel is composite materials such as those sold under the trade nameAccura Bluestone™ manufactured by 3D Systems Corporation (Rock Hill,S.C.), polycarbonates, or other high temperature plastics, andpreferably a material that does not absorb heat from the coil tube 210.

Without intending to being bound to theory, the mandrel provides forseparation of individual coils and limits the contact surface areabetween the metal tubing and the mandrel which results in less energybeing absorbed to the mandrel. It is desirable to limit the energyabsorbed to the mandrel.

Applicant recognized the above described phenomena. In embodiments ofthe invention, the contacting ratio (area in contact/area of entiretubing not in contact) is maintained to a range of 5 to 30%, and morepreferably from 5 to 15%, and most preferably to less than or equal to10%.

Additionally, the coil support 220 provides separation (namely, gaps)between individual coils. The spacing between the coil turns preventsthe touching/shorting with each other to maintain the correct electricalproperties when a voltage difference is applied along the length of thecoil.

Vapor Generating Element—Coil

FIGS. 6A-6C show a tube (e.g., a steel hypotube) arranged in a coil 210.The coiled arrangement 210 includes a plurality of individual coil turns216 a, 216 b, etc. In embodiments, the number of coil turns range from10-20 turns. As fluid is transported through the coil, and a voltagedifference is applied across the tube, the coil is heated to atemperature sufficient to vaporize the fluid therein. Without intendingto being bound to theory, it is desirable to incorporate more coil turnsinto the tubular member to increase the heat transferred to the liquidin view of the limited volume/spacing within the handpiece.

In embodiments, the overall diameter (ϕ) of the coiled arrangement 210ranges from 1 to 1.5 inches and preferably ranges from about 1 to 1.2inches. Spacing between the coil turns can be maintained by the mandrelreceptacles or cups 242 described above. In embodiments, the axiallength of the coil is adapted to allow the coil to fit within the barreland traverse to the barrel axis. In embodiments, the axial length (l) ofcoil is about the same as the mandrel, or about 1.5 to 1.75 inches.

The coiled arrangement 210 can be formed by winding a tubular memberinto the coiled arrangement. The tubular member includes a lumen totransport the fluid therethrough, and is made of an electricallyconductive material. An exemplary material for the tubular member is316L Stainless Steel welded and drawn tubing—passivated with an OD inthe range from 0.05 to 0.1, and preferably about 0.072 inches; and an IDin the range from 0.03 to 0.1, and preferably about 0.06 inches.

The path length for the liquid or fluid to travel from the coil entrance212 to the coil exit 214 ranges from 1000-2000 mm, and in embodimentsranges from about 1000-1300 mm. Increasing the path length serves totransfer more heat to the liquid, and to vaporize the liquid as theliquid flows therethrough. As stated herein, in embodiments, the pathlength is increased by incorporating more turns into the tubular member.

In embodiments, the vapor path is adapted to withstand high pressurewithout leaking such as a pressure of 125 psi when heated to 250° C.Exemplary materials for the vapor path 162 include those described abovein connection with the coil and which can withstand the desirableoperating pressures.

FIG. 7 is a perspective side view of another coil 310 registered withthe coil support 320 in accordance with one embodiment of the invention.The assembly is heat efficient in the sense that a substantial amount ofheat may be applied to the liquid in a relatively small space within thehandpiece. Also, the mandrel 320 holds the coil in place, traverse tothe barrel, and maintains spacing between each turn so the coil does notelectrically short.

In embodiments, the coil 310 is interlocked with the mandrel 320 byscrewing the coil onto the mandrel (or vice versa) just as one wouldinterlock a screw and nut.

Other modifications and variations can be made to the disclosedembodiments without departing from the subject invention.

For example, in embodiments, both the set and vapor switches are notrequired and only one vapor or trigger switch is present to commence thevapor delivery.

Additionally, in embodiments, the vapor generating element is maintainedparallel or in axial alignment with the barrel of the handpiece.

In embodiments, a vapor ablation system comprises a controller; a fluidsupply to supply liquid; a handpiece comprising a vapor generatingelement held in a coiled arrangement by a mandrel, the vapor generatingelement operable with the controller to heat the liquid flowingtherethrough into vapor; and an elongate catheter. In embodiments, thefluid supply may be a syringe.

In embodiments, the vapor generating element comprises an electricallyconducting tube and a plurality of coil turns.

In embodiments, the vapor ablation system further comprises a mandrel,and the mandrel has a plurality of exteriorly disposed receptacles, andeach receptacle sized to engage a coil turn of the electricallyconducting tube.

In embodiments, the electrically conducting tube and mandrel areinterlockingly arranged such that a contacting ratio of an area of thetube making contact with the mandrel is less than or equal to 10%.

In embodiments, the tube has a path length greater or equal to 1000 mm.In embodiments, the tube is fully contained within the body of thehandpiece.

In embodiments, a method for ablating tissue with condensable vaporcomprises the following steps: providing an electrically conducting tubein a coiled arrangement; maintaining a gap between adjacent coil turns;transporting liquid through the tube; applying a voltage differenceacross the tube from a first end to a second end thereby converting theliquid to a condensable vapor; and delivering the condensable vapor tothe tissue.

In embodiments, the method further comprises cooling the coil turns.

In embodiments, the maintaining step is performed with a mandrel.

In embodiments, the coil is interlocked with the mandrel by threadingthe coil and mandrel together.

We claim:
 1. A vapor ablation handpiece for assisting a physicianperform vapor ablation with a vapor ablation catheter, the handpiececomprising: a body comprising a proximal end and a distal end, whereinthe distal end is adapted to engage a proximal section of the vaporablation catheter; a liquid input port for receiving a liquid; a vaporgenerating element comprising a first end, a second end, and anelectrically conducting tube in a coiled arrangement comprising aplurality of coil turns; a mandrel attached to the body supporting thevapor generating element in the coiled arrangement; and a firstelectrical conductor in electrical communication with the first end ofthe vapor generating element, and a second electrical conductor inelectrical communication with the second end of the vapor generatingelement for supplying a voltage difference across the vapor generatingelement when activated and causing the vapor generating element to heatliquid therein converting the liquid to vapor.
 2. The vapor ablationhandpiece of claim 1 wherein the mandrel maintains a gap betweenadjacent coil turns.
 3. The vapor ablation handpiece of claim 1 whereinan axial length of the electrically conducting tube from the first endto the second end is at least 1 inch.
 4. The vapor ablation handpiece ofclaim 1 wherein the electrically conducting tube has an inner diameterin the range from 0.05 to 0.1 inches.
 5. The vapor ablation handpiece ofclaim 1 wherein the coiled arrangement has a diameter in the range from1 to 1.5 inches.
 6. The vapor ablation handpiece of claim 2 wherein eachsaid gap between the coil turns is at least 0.05 inches.
 7. The vaporablation handpiece of claim 1 further comprising a switch forcontrolling a function of the vapor ablation catheter when the vaporablation catheter is connected to the vapor ablation handpiece.
 8. Thevapor ablation handpiece of claim 7 wherein the switch activates thevapor catheter to deliver vapor continuously.
 9. The vapor ablationhandpiece of claim 1 further comprising at least one light device toindicate status of the handpiece.
 10. The vapor ablation handpiece ofclaim 1 wherein the body is pistol-shaped.
 11. The vapor ablationhandpiece of claim 10 further comprising a hook-shaped projection forhanging the handpiece.
 12. The vapor ablation handpiece of claim 1wherein the coiled arrangement is traverse relative to the body of thehandpiece.
 13. The vapor ablation handpiece of claim 1 furthercomprising a fan aimed at the electrically conducting tube.
 14. Thevapor ablation handpiece of claim 1 further comprising at least onethermocouple.
 15. The vapor ablation handpiece of claim 1 wherein theelectrically conducting tube is a steel.
 16. The vapor ablationhandpiece of claim 1 further comprising a flexible electrical cableextending from the proximal end of the handle, and said cable comprisinga connector for connecting to a vapor ablation controller.
 17. The vaporablation handpiece of claim 1 wherein the mandrel comprises a frame, anda plurality of receptacles, and wherein each receptacle is sized toaccept an individual coil turn and hold the individual coil turn inplace and to maintain a gap between adjacent coil turns.
 18. The vaporablation handpiece of claim 17 wherein the coiled arrangement includesat least 15 coil turns.
 19. A vapor ablation system comprises: acontroller; a fluid supply to supply liquid; and a handpiece couplingthe liquid to an elongate catheter wherein the handpiece comprises avapor generating element held in a coiled arrangement by a mandrel andwherein the vapor generating element is operable with the controller toheat liquid flowing therethrough into vapor, and pass the vapor throughthe elongate catheter.
 20. A method for ablating tissue with condensablevapor comprises: transporting a liquid through an electricallyconducting tube; applying a voltage difference across the electricallyconducting tube from a first end to a second end thereby converting theliquid to a condensable vapor; and delivering the condensable vapor tothe tissue.